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FDA 510(k)

MectaLock All-Suture Anchors

K-Number: K193461 · 2020-02-06

ApplicantMedacta International S.A.
Decision Date2020-02-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLock All-Suture Anchors is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-02-06 under approval number K193461. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaLock All-Suture Anchors?

MectaLock All-Suture Anchors is a medical device that received FDA 510(k) clearance on 2020-02-06. It is manufactured by Medacta International S.A.. The 510(k) number is K193461.

When was MectaLock All-Suture Anchors approved by the FDA?

MectaLock All-Suture Anchors received FDA 510(k) clearance on 2020-02-06, under approval number K193461.

What company makes MectaLock All-Suture Anchors?

MectaLock All-Suture Anchors is manufactured by Medacta International S.A..

What is the FDA product code for MectaLock All-Suture Anchors?

The FDA product code for MectaLock All-Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Medacta International S.A.

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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